- Remuneration package: Up to SGD$8,000 Basic + Variable Bonus
- Location: Yishun
- 5 Days office hours
Description
- Responsible for spearheading, implementing, and maintaining the Company’s Quality Management System in compliance with:
- MOH Healthcare Services Act and other regulatory relevant to the company’s services and products
- accreditation and certification standards: AABB (Association for the Advancement of Blood and Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), GDP-MDS SS 620 (Good Distribution Practice for Medical Devices) and other standards when required for the CGL’s services and products
- Ensure requirements for AABB, FACT and MOH license guidelines are implemented and maintained
- Report performance of the quality activities minimally on a quarterly basis and conduct a management review annually.
- Responsible for interfacing with regulators and external quality auditors.
- Monitor and review quality indicators and quality-related reports.
- Provide guidance to departments in the review and refinement of current practices, protocols, processes and risk assessment
- Lead / Facilitate other departments in the root cause analysis of non-conformances to put in place effective corrective actions.
- Facilitate proper process control relevant to services and products that affects safety, identity, purity and potency.
- Initiate process improvement practices and benchmark industry practices across departments to raise standards of operational excellence and service delivery
- Training and distribution of Quality practices within Company and regional teams when required.
- Act as company’s management representative in compliance assessments and coordinate with regulatory or accreditation bodies as and when required.
- Oversee the maintenance of document control centre and system for proper and updated records of quality documents.
- Lead the monitoring of quality objectives and indicators across departments to ensure the quality of products and services is maintained according to SOP and regulatory and accreditation requirements.
- Review processing records and other reports as required by applicable regulatory and/or accreditation standards.
- Drive yearly internal audits for audit readiness and interdepartmental coordination.
- Ensure quality training for new and existing employees is performed and to ensure competencies of the quality department are up-to-date.
- Support supplier/vendor qualifications with participating departments.
- Coordinate and review, on a periodic basis, operational and quality risk assessments, including workplace safety.
- Review, perform and lead gap analysis of new/revised standards published by regulatory and accreditation bodies to ensure departmental SOPs are in compliance
- Setting up of Quality Management Practices and assisting in risk assessment for new services or entities assigned
Requirements
- Degree At least 5 years of working experience in Quality Management, preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry, and at least 2 years in a managerial position.
- Led organization in regulatory assessments, accreditation preparation and audits
- Process improvement knowledge and experience
- Ability to handle tight deadlines and irregular situations
- Good change agent has the ability to positively influence others to facilitate a quality and change mindset
- Good communication skills
- Candidates with more experience will be considered for a Senior role
All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits
We regret that only shortlisted candidates will be notified
People Profilers Pte Ltd
20 Cecil Street, #08-09 PLUS Building Singapore 049705
EA License Number: 02C4944
Registration Number: R23114519
Posting Personnel: Lin Pei Yu
